Mechanical Low Back Pain Clinical Trial
— Pold-LBPOfficial title:
Effectiveness of Resonant Oscillation, According to the Pold Concept in Chronic Nonspecific Low Back Pain
NCT number | NCT01591824 |
Other study ID # | Pold-LBP |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2012 |
Est. completion date | September 2015 |
Verified date | April 2019 |
Source | Omphis Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Through this research is to conduct a pilot clinical trial in the treatment of chronic
nonspecific low back pain (degenerative and mechanical), by comparing two groups, one that
will apply a technique of physiotherapy by passive movement of the column with oscillations
in axial rotation at a frequency of 1.5 to 2 cps (resonance) of low amplitude (called "Pold
Concept"), another group that applies the standard protocol of treatment for this condition,
as used in the hospital where performed the study.
It will compare the levels of efficiency and effectiveness of each treatment and the
comparison between them. This will measure the perception of pain intensity and disability.
Status | Completed |
Enrollment | 50 |
Est. completion date | September 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Having a diagnosis instrumental prior to treatment to rule out pathologies pollutants, neurological or structural malformations. - No previous trauma. - Age between 25 and 65. - With similar clinical characteristics to have a homogenous group: - Low back pain (> 3 months) and that at the time the study began have a minimum of 3/10 on VAS scale, following the criteria established in similar studies - without component of neurological lower limbs irradiation Exclusion Criteria: - Existence of other recent traumatic structural pathologies in the lumbar region or of another type that could disturb the study. - Existence of irradiation metameric to lower limbs - Current tumors in the lumbar region - Ongoing infectious disease in the lumbar area. - Inflammatory rheumatism in the lumbar region. - Lumbar surgery complications. - Ongoing pregnancy. - They have been treated with infiltrations in the last month. - Who are following any other treatment, whether manual or physical agents or alternative or complementary therapies. |
Country | Name | City | State |
---|---|---|---|
Spain | Esperanza Hospital | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Omphis Foundation |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VAS pain measurement | Visual analog scale of pain measurement, with values between zero and ten where zero is total absence of pain and 10 the maximum pain imaginable by the patient, distributed in a horizontal line, without intermediate numerical or graphic references. | Participants will be followed for the duration of treatment application, an expected average of 3 weeks. | |
Secondary | SF-12 Health Survey | The Health Questionnaire SF-12 is the adaptation made for Spain of the SF-12 Health Survey. The SF-12 is a reduced version of the SF-36 Health Questionnaire. This instrument provides a profile of the state of health and is one of the most widely used generic scales in the evaluation of clinical outcomes, being applicable both for the general population and for patients with a minimum age of 14 years and both in descriptive studies and in evaluation. It consists of 12 items from the 8 dimensions of SF-36: Physical Function (2), Social Function (1), Physical Role (2), Emotional Role (2), Mental Health (2), Vitality (1), Pain body (1), General Health (1). Response options form Likert-type scales that evaluate intensity or frequency. The number of response options ranges from three to six, depending on the item |
Participants will be followed for the duration of treatment application, an expected average of 3 weeks. | |
Secondary | Oswestry Disability Index | The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. |
Participants will be followed for the duration of treatment application, an expected average of 3 weeks. |
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